Radioisotope-Guided Lymphadenectomy for Pelvic Lymph Node Staging in Patients with Intermediate- and High-risk Prostate Cancer (The Prospective SENTINELLE Study).

To prospectively evaluate the diagnostic accuracy of sentinel lymph node biopsy (SLNB)-guided lymph node dissection compared to extended pelvic lymph node dissection (ePLND) in patients with intermediate- or high-risk prostate cancer (PCa).

We conducted a prospective, single-arm, multicenter study at three tertiary centers in France between February 2012 and May 2019. Eligible patients had clinically localized, intermediate- or high-risk PCa. After intraprostatic injection of (99m)Tc-nanocolloid, the locations of the SLNs were defined by preoperative lymphoscintigraphy. Surgical excision of the SLNs was performed using intraoperative gamma probe guidance. After resection of the SLNs, ePLND was performed in all patients. We assessed the diagnostic accuracy of the SLNB method using ePLND as the reference standard. This trial was registered in ClinicalTrials.gov (NCT02732392).

A total of 162 men cN0M0 (CT scan and bone scan) were enrolled: 106 (65.4%) and 56 (34.6%) patients had intermediate- and high-risk PCa, respectively. The median number of nodes retrieved was 14 (mean 16, IQR 10-21) per patient. At final pathological analysis, 22 patients (13.6%) were pN+. Sensitivity, specificity, negative predictive value and positive predictive value of SLNB method in detecting patients with at least one LNM were 95.4% (95% CI 75.1-99.7), 100% (95% CI, 96.6-100), 99.2% (95% CI, 95.5-99.9) and 100 % (95% CI, 80.7-100), respectively.

Our multicenter prospective study supports that SLNB is a very effective and sensitive method for pelvic lymph node staging in patients with intermediate- or high-risk localized PCa.

The Journal of urology. 2022 Nov 04 [Epub ahead of print]

François Lannes, Michael Baboudjian, Alain Ruffion, Mathieu Rouy, Francesco Giammarile, Thierry Rousseau, Françoise Kraeber-Bodéré, Caroline Rousseau, Daniela Rusu, Mathilde Colombié, Isabelle Brenot-Rossi, Dominique Rossi, Nicolas Mottet, Cyrille Bastide

Department of Urology, North Hospital, Aix-Marseille University, APHM, Marseille, France., Department of Urology, Hospices Civils de Lyon, Lyon, France., Aix-Marseille University, 58 Bd Charles Livon 13007, Marseille, France., Nuclear Medicine and Diagnostic Imaging Section, Division of Human Health, Department of Nuclear Sciences and Applications, International Atomic Energy Agency, Vienna, Austria., Department of Urology, Clinique Urologie Nantes Atlantis, Saint Herblain, France., Nantes University, CHU Nantes, CNRS, Inserm, CRCINA, 44000 Nantes, France., Department of Nuclear Medicine, Institut Paoli-Calmettes, Marseille, France., Department of Urology, University Jean Monnet, St. Etienne, France.

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